HL Mando has patented a composition for intravenous injection containing beta-cyclodextrin molecules with hydroxypropyl groups, suitable for treating Niemann-Pick disease Type C. The composition is pharmaceutically acceptable for intravenous administration, with strict limits on endotoxins, propylene glycol, and propylene oxide. GlobalData’s report on HL Mando gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on HL Mando, Driving behavior monitoring was a key innovation area identified from patents. HL Mando's grant share as of February 2024 was 83%. Grant share is based on the ratio of number of grants to total number of patents.
Intravenous composition of beta-cyclodextrin molecules for niemann-pick disease treatment
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A recently granted patent (Publication Number: US11918601B2) discloses a composition for intravenous injection that includes a mixture of beta-cyclodextrin molecules substituted with hydroxypropyl groups. The composition is designed for intravenous administration and meets stringent pharmaceutical standards, containing less than 2 Endotoxin Units (EU) of endotoxins per gram, no more than 0.5% propylene glycol, and less than 1 ppm of propylene oxide. Additionally, the composition includes sodium chloride at 0.9% w/v, has a pH range of 6.0-8.0, is sterile filtered, and can be stored at 15-25°C.
Furthermore, the patented composition has specific limitations on the presence of unsubstituted beta-cyclodextrin and various degrees of hydroxypropyl substitution. The mixture must contain less than 3.5% collectively of unsubstituted beta-cyclodextrin, beta-cyclodextrin with one hydroxypropyl group, and beta-cyclodextrin with two hydroxypropyl groups. Additionally, the composition must have an osmolality of about 300 to 450 mOsm/kg, an average degree of substitution of 3 to 7, and a total impurity content of less than or equal to 0.05% as measured by HPLC. With a concentration ranging from 10 mg/mL to 200 mg/mL, this composition is suitable for intravenous administration to patients and can be further formulated with a pharmaceutically acceptable diluent for enhanced efficacy.
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